Treatment of Aggressive Periodontitis With Repeated Adjunctive Antimicrobial Photodynamic Therapy

NCT02049008 | Completed Phase 4 DMC

• 1 other identifier: 2012/13260-8 FAPESP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians, because there are no standardized protocols for efficient control of the disease. The aim of this study is to evaluate the effect of multiple applications of antimicrobial photodynamic therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a split-mouth design study to either aPDT associated with scaling and root planning (SRP) or SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in four episodes (days 0, 2, 7 and 14). All patients will be monitored for 90 days. Clinical assessment of plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the nsPT. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at baseline and 14, 30 and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained will be statistically analyzed.

Conditions

Aggressive Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in clinical attachment level at +90 days.

  The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +90 days after the non-surgical periodontal therapy.

Secondary Outcomes (3)

• Change from baseline in counts of 40 subgingival bacterial species at +30 and +90 days

  Microbiological monitoring (at baseline and +30 and +90 days after the non-surgical periodontal therapy) using the checkerboard DNA-DNA hybridization

• Change from baseline in levels of IL-1β, IL-10 and TNF-alpha at +14 and +30 and +90 days

  Immunological monitoring (at baseline, +14 and +30 and +90 days after the non-surgical periodontal therapy) using Luminex.

• Numbers of patients requiring additional periodontal treatment at +90 days.

  Considering each group separately, it will be evaluate the number of patients presenting at least a site with PPD≥5 mm and positiveBOP at 90 days post-therapy.

Study Arms (2)

Photodynamic Therapy

EXPERIMENTAL

Other: Photodynamic Therapy

Sham Photodynamic Therapy

SHAM COMPARATOR

Other: Sham Photodynamic Therapy

Interventions

Photodynamic Therapy OTHER

After a full-mouth scaling and root planning (SRP), the periodontal pockets of teeth selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride- 10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with distilled water to remove the excess of dye. The stained area will be irradiated with a diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated (10 seconds/ site). The applications of aPDT will be repeated in the same way until the second week (days: 2, 7,14). Before the application, the supragingival plaque will be removed.

Photodynamic Therapy

Sham Photodynamic Therapy OTHER

After a full-mouth scaling and root planning (SRP), the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. The simulations of aPDT will be repeated in the same way until the second week (days: 2, 7,14). Before the application, the supragingival plaque will be removed.

Sham Photodynamic Therapy

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• subjects with \<35 years old;
• a minimum of 20 teeth present;
• two pairs of single-rooted teeth in opposite sides with proximal sites showing probing depth and clinical attachment level ≥ 5 mm.

You may not qualify if:

• Positive history of antibiotic-therapy in the last six months;
• Positive history of basic periodontal treatment in the last six months;
• Systemic disease that can interfere with the progression of disease or response to treatment (eg, diabetes, immune disorders);
• Extensive prosthetic involvement;
• Need for antibiotic prophylaxis for performing routine dental procedures;
• Use of anti-inflammatory drugs for long periods of time;
• Smoking
• Pregnancy.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

School of Dentistry of Ribeirao Preto - University of São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Michel R Messora, Dr.

  University of São Paulo - Ribeirão Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: January 29, 2014
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 3, 2014

Record last verified: 2014-04

Locations

BR (1)